Form 483

P&S Ravioli Company Form 483, 2009-09-17

FDA issued a Form 483 to P&S Ravioli Company on 2009-09-17 with 6 public-safe observations.

483· Form 483 issued6 observations

P&S Ravioli Company · Philadelphia, United States · Issued September 17, 2009

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Sep 2009
21 CFR 110.35(b)(1)

Safe and adequate for use

Cited by Hala L Selby, Donyel M Jones, Linda M Hoover

17 Sep 2009
21 CFR 110.35(b)(2)

Storage requirements

Cited by Hala L Selby, Donyel M Jones, Linda M Hoover

17 Sep 2009
21 CFR 110.80(a)(1)

Storage

Cited by Hala L Selby, Donyel M Jones, Linda M Hoover

17 Sep 2009
21 CFR 123.6(b)

HACCP plan implementation

Cited by Hala L Selby, Donyel M Jones, Linda M Hoover

17 Sep 2009
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Hala L Selby, Donyel M Jones, Linda M Hoover

Inspected site

PRP&S Ravioli CompanyPhiladelphia, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.10Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere